Physiological, Hormonal, and DNA-based Mechanisms of Psychosocial Stress and Therapeutic Effect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Helsinki
About this trial
The goal of this trial is to learn if the Groups 4 Health (G4H) intervention is effective in supporting student well-being at the University of Helsinki. It will also learn about the factors that may influence the efficacy of the intervention (such as facilitators characteristics, stress physiology and changes in gene expression). The main questions it aims to answer are:
1. Is the G4H intervention effective and cost-effective in supporting student well-being? 2. To what extent participants' physiological, hormonal, or molecular characteristics mediate the therapeutic effect of the G4H 3. To what extent participants' genotype moderates the effect of the G4H 4. To what extent facilitators' characteristics mediate or moderate the effect of the G4H
Data is collected from both the intervention participants and the facilitators.
The G4H facilitators will:
* Facilitate the G4H intervention. * Fill in questionnaires and provide physiological and molecular measurements before, during, and after the G4H intervention.
The G4H participants will:
* Participate in the G4H intervention. * Fill in questionnaires and provide physiological, hormonal and molecular measurements before, during, and after the G4H intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult (age 18 and above)
Student in the University of Helsinki, Finland
Able to speak/read Finnish, Swedish, or English
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Groups 4 health
BehavioralGroups 4 Health (G4H) at the University of Helsinki is a manualized group intervention for the students that focuses on social connectedness and aims at improving general health and life satisfaction. G4H groups are facilitated by two psychology master's students (or licensed psychologists) carefully trained for the intervention and mentored by experienced clinical psychologists. G4H consists of five 90 minutes sessions that aim to give participants the knowledge and skills they need to effectively manage their social group memberships and identities. Each session contains exercises and discussions described in the G4H workbook that target different aspects of group life identified within the social identity model of identity change and put the Social Identity Approach to Health -model to practice. Students earn 2 European Credit Transfer and Accumulation System (ECTS) credits for completing the intervention.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Groups 4 Health InterventionExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Loneliness
Loneliness is measured with the 4 and 8-item short forms of the revised University of California, Los Angeles Loneliness Scale (ULS-4 and ULS-8, response options: 1=never, 2=rarely, 3=sometimes, 4=often, lower score means better outcome).
Time frame
1) Before the intervention, 2) During the intervention (week 3), 3) immediately after the intervention, 4) one month follow-up, 5) three months follow-up, 6) 12 months follow-up2
Depression
Symptoms of depression are assessed with the 9-item Patient Health Questionnaire (response options: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, lower score means better outcome).
Time frame
1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up3
Active group memberships
Multiple group memberships are assessed with the 4-item Exeter Identity Transition Scale (response options: 1 = strongly disagree, 7 = strongly agree, higher score means better outcome).
Time frame
1) Before the intervention, 2) During the intervention (week 3), 3) immediately after the intervention, 4) one month follow-up, 5) three months follow-up, 6) 12-months follow-up4
Mental well-being
Mental well-being is assessed with the 7-item Short Warwick-Edinburgh Mental Wellbeing Scale (response options: 1=not at all, 2=rarely, 3=occasionally, 4=often, 5=all the time, higher score means better outcome).
Time frame
1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-upSecondary outcomes
1
Perceived Stress
Perceived stress is measured with the 10-item Perceived Stress Scale (response options: 0 = never, 1 = almost never, 2=sometimes, 3=fairly often, 4=very often, lower scores means better outcome)
Time frame
1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up2
Self- and other-compassion
Self- and other-compassion is measured with the 4-item Process Based Assessment Tool (response options: 1=very seldom to 5=very often, higher scores means better outcome)
Time frame
1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up3
Health-related quality of life
Health-related quality of life is measured with the Euro Quality of Life - 5 dimension - 5 level questionnaire (EQ-5D-5L). The measure has 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) comprising of five statements of which the respondent can choose the option that best describes their situation. Higher score means better outcome. This measure is used to calculate the cost-effectiveness of the interventions.
Time frame
1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up4
Use of social and health care services
The use of social and health care services for mental health is measured with a self-report questionnaire (medications, health care appointments, hospitalization, counseling). The use of health care services will be monetarized by using Finnish national unit costs. This measure is used to calculate the cost-effectiveness of the interventions.
Time frame
1) Before the intervention, 2) immediately after the intervention, 3) three months follow-upOther outcomes
1
Mood
Mood is measured with scale from 0 (extremely bad mood) to 7 (extremely good mood)
Time frame
1) Before the intervention, 2) During the intervention (week 3), 3) immediately after the intervention, 4) one month follow-up, 5) three months follow-up, 6) 12-months follow-up2
Identification with the intervention
Identification with the intervention group is assessed with the Single-Item Social Identification -measure (response options: 1 = fully disagree, 7 = fully agree, higher score means better outcome).
Time frame
During intervention (week 3)3
Participant adherence
The number of participants consented vs the number of participants completing the intervention, attendance rate of individual sessions
Time frame
Immediately after each intervention session, during 8 weeks4
Facilitator's fidelity to the manual
To monitor fidelity to the G4H manual, the facilitators of the G4H groups will complete a short checklist at the end of each session to determine compliance to the protocol.
Time frame
Immediately after each intervention session, during 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Helsinki
Lead sponsor
Strategic Research Council, Finland
Collaborator
University of Eastern Finland
Collaborator
Finnish Institute for Health and Welfare
Collaborator
Finnish Cultural Foundation
Collaborator
Source ClinicalTrials.gov